COVID-19. COVID-19
Conditions
Interventions
Intervention 1: Intervention group:Favipiravir administered orally, produced by the Dr. Abidi pharmacutical Co, Iran, 3200mg (1600/ bid) on the first day followed by 1200mg (600mg/bid) daily for the
Sponsors
Dr. Abidi pharmacutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with mild to moderate COVID-19 symptoms (According to the national guidance definitions) with positive PCR test for COVID-19 At least 18 years old Less than 10 days from the onset of symptoms
Exclusion criteria
Exclusion criteria: History of liver disorders (specifically active liver disorders and liver dysfunction included: ALT/AST > 1.5 ULN and ALP > 2.5 ULN and total Bilirubin>1.25 ULN) Allergy to Favipiravir or its ingredients Pregnancy and lactation History of gastrointestinal(GI) disorders such as GI bleeding or GI inflammatory diseases or history of GI surgery that intervene in the Favipiravir absorption process History of active or latent tuberculosis Active infection other than COVID-19 Abnormal metabolism of uric acid/ Gout Abnormal test results in the screening stage that need more clinical assessments Participation in any type of clinical trials in the last 30 days Any psychological disorders that affects patient compliance of the study protocol Any disease or disorder that investigators believed might put participants in an excess risk, if they were included or history of allergy to any antiviral nocleoside-analog drugs with viral RNA polymerase inhibition mechanism Active HBV, HCV HIV or any other known immunological disorders or using immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Turning PCR test result into negative. Timepoint: The 6th day and the 14th day after the intervention commence. Method of measurement: Laboratory PCR test for diagnosis of COVID-19.;Time to recovery of symptoms(fever and cough). Timepoint: up to 14 days after the intervention commence. Method of measurement: telephone call examination.;Symptoms recovery(fever and cough). Timepoint: day 6, day 14 and day 28 after the intervention commence. Method of measurement: telephone call examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and adverse reactions. Timepoint: up to the 28th day of follow up. Method of measurement: telephone call examination and/or lab tests.;ICU admission. Timepoint: up to 28 days after the commence of the intervention. Method of measurement: telephone call follow up.;Mortality. Timepoint: up to 28 days after the commence of the intervention. Method of measurement: telephone calls follow up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAyat Ahmadi
Tehran University of Medical Sciences
Outcome results
None listed